| no clinical added value |
Considering:
- efficacy data obtained solely from four bibliographic studies, with:
- evidence of superiority in the short term only:
- in children and adolescents aged 6 to 17 years: versus atomoxetine for the time to clinical response demonstrated by a CGI-I score of 1 or 2 point(s), an endpoint not specific to ADHD and of debatable clinical relevance, after 9 weeks of treatment, with a mean difference of -9 days,
- in adolescents aged 13 to 17 years: versus placebo for the severity of ADHD symptoms demonstrated by a change from baseline in ADHD-RS score after 4 weeks of treatment, with a mean difference of -5.5 to -8.3 points (p≤ 0.0056), depending on the treatment doses,
- the lack of evidence in adolescents aged 13 to 17 years of a superiority for ADHD symptom severity in terms of change from baseline in total ADHD-RS score after 8 weeks of treatment between lisdexamphetamine at an optimal dose and prolonged-release methylphenidate,
but in view of:
- the different limitations associated with these studies (short-term assessment, exclusion of patients with psychiatric comorbidities, uncertainty as to whether the treatment really was initiated following the failure of non-medicinal remedial measures and when response to previous methylphenidate treatment is considered clinically inadequate, particularly in adolescents aged 13 to 17 years, uncertainty with respect to the transposability of the findings to the French population),
- the absence of robust efficacy data for ADHD symptoms in children aged 6 to 12 years,
- the absence of robust quality of life data,
- the lack of robust comparative data versus the available alternatives,
- the safety profile, with cardiovascular, neuropsychiatric, cerebrovascular and height/weight risks, as well as uncertainties in the long term,
the Committee deems that XURTA (lisdexamphetamine) 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg hard capsules provides no clinical added value (CAV V) as part of a comprehensive treatment programme for ADHD in children aged 6 years and over when response to previous methylphenidate treatment is considered clinically inadequate.
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